EN 61157:2007
(Main)Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
Establishes requirements for the declaration of the acoustic output information: 1.to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers; 2.to be declared in the accompanying literature/ manual supplied by manufacturers; 3.as background information to be made available on request to interested parties by manufacturers.
Normverfahren für die Angabe der akustischen Ausgangsgrößen von medizinischen Ultraschalldiagnostikgeräten
Critères normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons
Définit les critères pour la déclaration des informations intéressant les émissions acoustiques: 1. à présenter dans des bordereaux de données techniques fournis par les fabricants aux acheteurs éventuels des appareils; 2. à déclarer dans la documentation/le manuel d'accompagnement fournis par les fabricants; 3. sous la forme d'informations de fond devant être présentées, sur demande, aux parties intéressées par les fabricants.
Standardni načini poročanja o akustičnem izhodu medicinske ultrazvočne diagnostične opreme (IEC 61157:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2008
1DGRPHãþD
SIST EN 61157:2002
6WDQGDUGQLQDþLQLSRURþDQMDRDNXVWLþQHPL]KRGXPHGLFLQVNHXOWUD]YRþQH
GLDJQRVWLþQHRSUHPH ,(&
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic
equipment
Normverfahren für die Angabe der akustischen Ausgangsgrößen von medizinischen
Ultraschalldiagnostikgeräten
Moyens normalisés pour la déclaration des émissions acoustiques des appareils de
diagnostic médical à ultrasons
Ta slovenski standard je istoveten z: EN 61157:2007
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 61157
NORME EUROPÉENNE
November 2007
EUROPÄISCHE NORM
ICS 11.040.50; 11.140.50 Supersedes EN 61157:1994
English version
Standard means for the reporting of the acoustic output
of medical diagnostic ultrasonic equipment
(IEC 61157:2007)
Moyens normalisés pour la déclaration Normverfahren für die Angabe
des émissions acoustiques des appareils der akustischen Ausgangsgrößen
de diagnostic médical à ultrasons von medizinischen
(CEI 61157:2007) Ultraschalldiagnostikgeräten
(IEC 61157:2007)
This European Standard was approved by CENELEC on 2007-10-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61157:2007 E
Foreword
The text of document 87/356/CDV, future edition 2 of IEC 61157, prepared by IEC TC 87, Ultrasonics,
was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by
CENELEC as EN 61157 on 2007-10-01.
This European Standard supersedes EN 61157:1994.
The changes with respect to EN 61157:1994 are listed below:
– maintenance on this standard and the referenced standards EN 61161 and EN 62127-1;
– a clause on compliance has been added.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-07-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-10-01
NOTE The following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in Clause 3.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61157:2007 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 61689 NOTE Harmonized as EN 61689:2007 (not modified).
IEC 61828 NOTE Harmonized as EN 61828:2001 (not modified).
__________
– 3 – EN 61157:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60050-801 1994 International Electrotechnical Vocabulary – –
(IEV) -
Chapter 801: Acoustics and electroacoustics
1) 2)
IEC 61161 – Ultrasonics - Power measurement - EN 61161 2007
Radiation force balances and performance
requirements
1) 2)
IEC 62127-1 – Ultrasonics - Hydrophones - EN 62127-1 2007
Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz
ISO 16269-6 2005 Statistical interpretation of data - – –
Part 6: Determination of statistical tolerance
intervals
ISO/IEC Guide 98 1995 Guide to the expression of uncertainty in – –
measurement (GUM)
1)
Undated reference.
2)
Valid edition at date of issue.
IEC 61157
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
V
ICS 11.040.50; 11.140.50 ISBN 2-8318-9257-0
– 2 – 61157 © IEC:2007(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.6
2 Normative references .6
3 Terms, definitions and symbols .6
4 Requirements .16
4.1 General .16
4.2 Requirements for the reporting of acoustic output information .17
4.2.1 Technical data sheets information format .17
4.2.2 Detailed operating mode data sheets information format .18
4.2.3 Background information.19
4.2.4 Diagnostic fields in the absence of scan-frame synchronization.20
4.2.5 Dataset for low acoustic output equipment.20
5 Compliance statement .21
5.1 General .21
5.2 Maximum probable values .21
5.3 Sampling .21
6 Test methods .22
7 Presentation of results.22
Annex A (normative) Presentation of acoustic output information.23
Annex B (informative) Reporting requirements for extensive systems .25
Annex C (informative) Rationale .26
Index of defined terms .30
Bibliography.32
Figure C.1 – Schematic diagram showing the relationship between the various defined
surfaces and distances for a mechanical sector scanner with water stand-off
distance when applied to a patient.27
Figure C.2 – Schematic diagram showing the relationship between the various defined
parameters and distances for a mechanical sector scanner during the
measurement of acoustic output .27
Figure C.3 – Schematic diagram showing various defined parameters associated with
the distribution of the scan lines in a linear array scanner and mechanically-
scanned sector scanner.28
Figure C.4 – Schematic diagram illustrating the peak-rarefactional acoustic pressure
during an acoustic pulse.29
Table 1 – List of symbols .15
Table A.1 – An example of reporting of the acoustic output of a 3,5 MHz scan-head for
a phased-array sector scanner in accordance with this standard.24
61157 © IEC:2007(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61157 has been prepared by IEC technical committee 87:
Ultrasonics.
This second edition cancels and replaces the first edition published in 1992. This edition
constitutes a minor revision.
The changes with respect to the previous edition are listed below:
• maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1.
• a clause on compliance has been added.
The text of this standard is based on the following documents:
Enquiry draft Report on voting
87/356/CDV 87/374/RVC
– 4 – 61157 © IEC:2007(E)
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordanc
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